ApprovalTrail

Medical device licence · 100376 · Class 3

INMODE SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed January 16, 2018. It is in Health Canada’s list of active licences.
Licence number
100376
Licence holder
Inmode Ltd.Yokneam, Israel
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
January 16, 2018
Devices covered
19

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • BODYFX
  • DIOLAZE
  • DIOLAZE XL
  • FORMA
  • FORMA-I
  • FRACTORA
  • INMODE
  • LUMECCA
  • MINIFX
  • MORPHEUS8
  • MORPHEUS8 RESURFACING TIP
  • MORPHEUS8 TIP
  • MORPHEUS8-12 TIP
  • MORPHEUS8-40 TIP
  • PLUS
  • PLUS90
  • TIPS
  • TRITON
  • VASCULAZE

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.